David E. De Lorenzi Sheila F. McShane GIBBONS P.C.

One Gateway Center Newark, New Jersey 07102 Telephone: (973) 596-4500 Facsimile: (973) 596-0545 Dimitrios T. Drivas Jeffrey J. Oelke James S. Trainor, Jr. Ryan P. Johnson WHITE & CASE LLP 1155 Avenue of the Americas New York, New York 10036 Telephone: (212) 819-8200 Facsimile: (212) 354-8113 Attorneys for Plaintiffs Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

PFIZER INC., PHARMACIA & UPJOHN COMPANY LLC, and PFIZER HEALTH AB, Plaintiffs, v.

Civil Action No.:_____ Document electronically filed.

LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants.

COMPLAINT

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Plaintiffs Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB (collectively, Pfizer), by their attorneys, White & Case LLP and Gibbons P.C., for their Complaint against Defendants Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively, Lupin), allege: THE PARTIES 1. Plaintiff Pfizer Inc., is a corporation organized and existing under the laws

of the State of Delaware, having a place of business at 235 East 42nd Street, New York, New York. 2. Plaintiff Pharmacia & Upjohn Company LLC is a corporation organized

and existing under the laws of the State of Delaware, having a place of business at 7000 Portage Road, Kalamazoo, Michigan. Pfizer Inc. is the ultimate parent of Pharmacia & Upjohn Company LLC. 3. Plaintiff Pfizer Health AB is a company organized and existing under the

laws of Sweden, having a place of business at SE-112 87, Stockholm, Sweden. Pfizer Inc. is the ultimate parent of Pfizer Health AB. 4. Upon information and belief, Defendant Lupin Ltd. is a company

organized and existing under the laws of India, having a principal place of business at Laxmi Towers, B Wing, Bandra Kurla Complex, Bandra (East), Mumbai, Maharashta 400 051, India. 5. Upon information and belief, Defendant Lupin Pharmaceuticals, Inc. is a

corporation organized and existing under the laws of the State of Virginia, having a principal place of business at 111 S. Calvert Street, Suite 2100, Baltimore, Maryland 21202. Upon information and belief, Lupin Pharmaceuticals, Inc. is a wholly owned subsidiary of Lupin Ltd.

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JURISDICTION AND VENUE 6. This Court has exclusive subject matter jurisdiction over this action

pursuant to 28 U.S.C. 1331 and 1338(a). 7. Upon information and belief, Lupin is in the business of making and

selling generic drug products. 8. Upon information and belief, Lupin conducts business in New Jersey and

sells various drug products in the United States, including in the State of New Jersey. 9. Upon information and belief, Lupin is registered to do business in the

State of New Jersey and has appointed National Registered Agents, Inc., located at 100 Canal Pointe Blvd., Suite 212, Princeton, NJ 08540, as its registered agent for service in New Jersey. 10. Lupin has been sued in this District and has previously submitted to the

jurisdiction of this Court. 11. Lupin has availed itself of the jurisdiction of this Court by asserting

counterclaims in lawsuits filed in this Court. 12. This court has personal jurisdiction over Lupin by virtue of, inter alia, the

allegations of paragraphs 8-11 of this Complaint. 13. 1400(b). U.S. Patent No. 6,630,162 14. On October 7, 2003, the United States Patent and Trademark Office issued Venue is proper in this District pursuant to 28 U.S.C. 1391 and

United States Patent No. 6,630,162 (the 162 patent), entitled Pharmaceutical Formulation

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and its Use. At the time of its issue, the 162 patent was assigned to Pharmacia AB. Pfizer Health AB currently holds title to the 162 patent. A copy of the 162 patent is attached hereto as Exhibit A. 15. The 162 patent is directed to and claims, inter alia, an oral pharmaceutical

formulation for administering tolterodine, as well as a method of treatment comprising administering a therapeutically effective amount of such a formulation. U.S. Patent No. 6,770,295 16. On August 3, 2004, the United States Patent and Trademark Office issued

United States Patent 6,770,295 (the 295 patent), entitled Therapeutic Formulation for Administering Tolterodine with Controlled Release. At the time of its issue, the 295 patent was assigned to Pharmacia & Upjohn AB. Pfizer Health AB currently holds title to the 295 patent. A copy of the 295 patent is attached hereto as Exhibit B. 17. The 295 patent is directed to and claims, inter alia, an improved method

of treating unstable or overactive bladder, as well as a formulation therefor. Detrol LA 18. Pharmacia & Upjohn Company LLC holds an approved New Drug

Application (the Detrol LA NDA) for tolterodine tartrate extended-release capsules, in 2 and 4 mg dosages, which are sold by Pfizer Inc., under the trade name Detrol LA. 19. Pursuant to 21 U.S.C. 355(b)(1), and attendant United States Food and

Drug Administration (FDA) regulations, the 162 and 295 patents are listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), with respect to Detrol LA.

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Lupins ANDA 20. Lupin submitted Abbreviated New Drug Application No. 204-689 (the

Lupin ANDA) to the FDA, pursuant to 21 U.S.C. 355(j), seeking approval to market tolterodine tartrate extended-release capsules, in 2 and 4 mg dosages (the Lupin Product). 21. The Lupin ANDA refers to and relies upon the Detrol LA NDA and

contains data that, according to Lupin, demonstrate the bioequivalence of the Lupin Product and Detrol LA. 22. On or about February 11, 2013, Pfizer received from Lupin a letter and

attached memorandum, dated February 8, 2013, stating that Lupin had included in its ANDA a certification, pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV), that each of the 162 and 295 patents is invalid, unenforceable, or would not be infringed by the manufacture, use, or sale of the Lupin Product. COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,630,162 23. Pfizer realleges and incorporates by reference the allegations of

paragraphs 1-22 of this Complaint. 24. Lupin has infringed the 162 patent, pursuant to 35 U.S.C. 271(e)(2)(A),

by submitting ANDA No. 204-689, by which Lupin seeks approval from the FDA to engage in the commercial manufacture, use, and/or sale of the Lupin Product prior to the expiration of the 162 patent. 25. If Lupin commercially makes, uses, offers to sell, and/or sells the Lupin

Product within the United States, or imports the Lupin Product into the United States, or induces or contributes to any such conduct during the term of the 162 patent, it would further infringe the 162 patent under 35 U.S.C. 271(a), (b), and/or (c).

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26.

Pfizer will be irreparably harmed if Lupin is not enjoined from infringing

the 162 patent. Pfizer does not have an adequate remedy at law. COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,770,295 27. Pfizer hereby realleges and incorporates by reference the allegations of

paragraphs 1-22 of this Complaint. 28. Lupin has infringed the 295 patent, pursuant to 35 U.S.C. 271(e)(2)(A),

by submitting ANDA No. 204-689, by which Lupin seeks approval from the FDA to engage in the commercial manufacture, use, and/or sale of the Lupin Product prior to the expiration of the 295 patent. 29. If Lupin commercially makes, uses, offers to sell, and/or sells the Lupin

Product within the United States, or imports the Lupin Product into the United States, or induces or contributes to any such conduct during the term of the 295 patent, it would further infringe the 295 patent under 35 U.S.C. 271(a), (b), and/or (c). 30. Pfizer will be irreparably harmed if Lupin is not enjoined from infringing

the 295 patent. Pfizer does not have an adequate remedy at law. PRAYER FOR RELIEF WHEREFORE, Pfizer prays for a judgment in its favor and against Lupin, as follows: A. B. C. That Lupin has infringed the 162 patent; That Lupin has infringed the 295 patent; That, pursuant to 35 U.S.C. 271(e)(4)(B), Lupin, its officers, agents,

servants, and employees, and those persons in active concert or participation with any of them, are preliminarily and permanently enjoined from making, using, selling, offering to

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sell the Lupin Product within the United States, or importing the Lupin Product into the United States prior to the expiration of the 162 and 295 patents; D. That, pursuant to 35 U.S.C. 271(e)(4)(A), the effective date of any

approval of ANDA No. 204-689 under 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)) shall not be earlier than the latest of the expiration dates of the 162 and 295 patents, including any extensions; E. That Plaintiffs be awarded monetary relief if Lupin commercially makes,

uses, sells, or offers to sell the Lupin Product within the United States, or imports the Lupin Product into the United States, prior to the expiration of any of the 162 and 295 patents, including any extensions, and that any such monetary relief be awarded to Plaintiffs with prejudgment interest; and F. proper. Dated: March 21, 2013 New York, NY That Plaintiffs be awarded such other relief as the Court deems just and

Respectfully submitted, By: s/ Sheila F. McShane David E. De Lorenzi Sheila F. McShane GIBBONS P.C. One Gateway Center Newark, New Jersey 07102 Telephone: (973) 596-4500 Facsimile: (973) 596-0545 Attorneys for Plaintiffs Pfizer Inc., Pharmacia & Upjohn Company LLC, and Pfizer Health AB

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OF COUNSEL Dimitrios T. Drivas Jeffrey J. Oelke James S. Trainor, Jr. Ryan P. Johnson WHITE & CASE LLP 1155 Avenue of the Americas New York, New York 10036 Telephone: (212) 819-8200 Facsimile: (212) 354-8113

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